ComposiTCP recallZ-1361-2022 · Science & Bio Materials · initiated Oct 7, 2021
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Science & Bio Materials or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeled product.
FDA root cause category: Process control
What the company is doing
The firm notified its US distributor of the recall by email on 30 September 2021. The notice requested quarantine of the device and for the distributor to notify all interested parties with their organization and to any organization to which the device was transferred.
Recall details
- Recall number
- Z-1361-2022
- Status
- Completed
- Initiated by the company
- Oct 7, 2021
- Recalling firm
- Science & Bio Materials
- Quantity
- 72 units
- Product code
- HWC
- FDA submissions
- K070507
- Distribution
- US Nationwide distribution.
Product description
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Code information (models, lots, serial numbers)
Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ComposiTCP ComposiTCP 30 round headS.B.M · Fastener, Fixation, Biodegradable, Soft Tissue1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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